Guides
Plain-language guides for hospital pharmacies, chemists, patients and pharma companies, written from the distribution floor and checked against the official sources.
- Basics, 5 minute read, updated
What is a specialty pharmaceutical distributor?
A specialty pharmaceutical distributor buys high-value, often temperature-sensitive medicines — cancer biologics, vaccines, transplant and critical-care drugs — from manufacturers and supplies them to hospitals, pharmacies and patients with batch-wise records, a validated cold chain and tighter control over who receives each pack. It handles fewer products than a general wholesaler, but each one needs more care.
- Regulation, 7 minute read, updated
Good Distribution Practice in India: what CDSCO expects from a distributor
Good Distribution Practice (GDP) is the set of controls that keep a medicine’s quality intact between the manufacturer and the patient. In India, CDSCO’s guidelines on Good Distribution Practices for Pharmaceutical Products ask distributors to store products as the manufacturer specifies, temperature-map and monitor storage, issue stock first-expiry-first-out, run written recall and complaint procedures, segregate suspected spurious products, keep batch-wise records and inspect themselves every year.
- Quality and safety, 5 minute read, updated
How to check if a medicine is genuine in India
Buy only from licensed pharmacies and distributors, check that the batch number, expiry and manufacturer details on the pack are complete and match the invoice, and scan the QR code where there is one: since 1 August 2023 India’s top 300 medicine brands must carry a QR code that shows the product’s identity, batch and expiry. If anything looks wrong, do not use the medicine and report it.
- Regulation, 4 minute read, updated
Wholesale drug licences in India: Form 20B, 21B and 20G explained
In India a pharmaceutical wholesaler needs a licence from the state drug control authority for each category it sells: Form 20B for drugs other than those in Schedules C, C(1) and X; Form 21B for Schedule C and C(1) products such as biologicals, vaccines and sera; and Form 20G for Schedule X drugs. The licences stay valid as long as a retention fee is paid every five years, and each premises needs a qualified competent person.
- Regulation, 4 minute read, updated
Schedule H, H1 and X medicines: what the labels and rules mean
Schedule H medicines carry the Rx symbol and may be sold only on a doctor’s prescription. Schedule H1 medicines, mostly newer antibiotics and anti-tuberculosis drugs, also carry a red-bordered warning box, and the chemist must record the patient, the prescriber and the drug sold in a register kept for three years. Schedule X medicines, the most tightly controlled, carry XRx and the chemist keeps a copy of the prescription.
- Sourcing, 5 minute read, updated
Biosimilars in India: a guide for hospital pharmacies
A biosimilar — called a similar biologic in India — is a biological medicine shown to be highly similar to an already approved reference biologic, with no clinically meaningful differences in safety or efficacy. CDSCO approves them under its similar-biologics guidelines. For hospital pharmacies they widen choice and can lower cost; the decision to use or switch rests with prescribers and the formulary committee, and each brand should be tracked separately.
- Cold chain, 5 minute read, updated
Storing 2–8 °C medicines in a hospital or pharmacy refrigerator
Keep refrigerated medicines in a purpose-built pharmaceutical refrigerator set to +2 °C to +8 °C, away from the walls, the cooling plate and the door, in their original packs, with the temperature checked and recorded at least twice a day. If the temperature goes out of range, quarantine the stock and ask the supplier or manufacturer before using it.
- Quality and safety, 6 minute read, updated
Appointing a specialty distributor in India: what your due diligence should cover
Before appointing a specialty distributor in India, a manufacturer should confirm the distributor holds the right wholesale drug licences, stores and moves product under Good Distribution Practice with a validated cold chain, keeps batch-wise records that support a recall, buys and sells only through licensed channels within the agreed territory, operates ethically, and can report stock and secondary sales in the manufacturer’s format.
- Cold chain, 6 minute read, updated
Pharmaceutical cold chain, explained: what 2–8 °C really takes
A pharmaceutical cold chain is the unbroken sequence of temperature-controlled storage and transport that keeps a medicine within its labelled range — usually +2 °C to +8 °C — from the manufacturer to the patient. It depends on mapped storage, continuous monitoring, validated packaging and a temperature record that travels with each consignment.
- Sourcing, 5 minute read, updated
How hospitals can source specialty oncology medicines reliably in India
Reliable oncology supply comes from three things: buying through distributors with direct manufacturer relationships, keeping more than one approved brand available for critical molecules, and insisting on documented cold-chain delivery for biologics. Planning around clinic schedules and known shortage risks prevents most last-minute crises.
Looking for a definition? See the glossary of pharma distribution terms, or download a checklist from free resources.